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FDA 510(k)

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module

K-Number: K193007 · 2020-01-17

ApplicantLina Medical Aps
Decision Date2020-01-17
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is a medical device manufactured by Lina Medical Aps. It received FDA 510(k) clearance on 2020-01-17 under approval number K193007. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module?

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Lina Medical Aps. The 510(k) number is K193007.

When was LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module approved by the FDA?

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module received FDA 510(k) clearance on 2020-01-17, under approval number K193007.

What company makes LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module?

LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is manufactured by Lina Medical Aps.

What is the FDA product code for LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module?

The FDA product code for LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module is HIH.

Other Devices by Lina Medical Aps

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K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc. K160751Symphion Endoscope and Symphion Cervical SheathBoston Scientific K160510MAKO 7Nvision Medical Corporation K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc. K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. K182006Omni Hysteroscope, Omni Hysteroscope Kits, Omni SheathsHologic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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